title: Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma.
abstract: We compared thalidomide-dexamethasone (TD) with melphalan-prednisolone (MP) in 289 elderly patients with multiple myeloma (MM). Patients received either thalidomide 200 mg plus dexamethasone 40 mg, days 1 to 4 and 15 to 18 on even cycles and days 1 to 4 on odd cycles, during a 28-day cycle or to melphalan 0.25 mg/kg and prednisolone 2 mg/kg orally on days 1 to 4 during a 28- to 42-day cycle. Patients achieving stable disease or better were randomly assigned to maintenance therapy with either thalidomide 100 mg daily and 3 MU interferon alpha-2b thrice weekly or to 3 MU interferon alpha-2b thrice weekly only. TD resulted in a higher proportion of complete and very good remissions (26% vs 13%; P= .006) and overall responses (68% vs 50%; P= .002) compared with MP. Time to progression (21.2 vs 29.1 months; P= .2), and progression-free survival was similar (16.7 vs 20.7 months; P= .1), but overall survival was significantly shorter in the TD group (41.5 vs 49.4 months; P= .024). Toxicity was higher with TD, particularly in patients older than 75 years with poor performance status. The study was registered at ClinicalTrials.gov as NCT00205751.
authors.affiliation: Department of Medicine I, Wilhelminenspital Vienna, Vienna, Austria. heinz.ludwig@wienkav.at
authors.forename: Heinz
authors.initials: H
authors.lastname: Ludwig
authors.forename: Roman
authors.initials: R
authors.lastname: Hajek
authors.forename: Elena
authors.initials: E
authors.lastname: Tóthová
authors.forename: Johannes
authors.initials: J
authors.lastname: Drach
authors.forename: Zdenek
authors.initials: Z
authors.lastname: Adam
authors.forename: Boris
authors.initials: B
authors.lastname: Labar
authors.forename: Miklós
authors.initials: M
authors.lastname: Egyed
authors.forename: Ivan
authors.initials: I
authors.lastname: Spicka
authors.forename: Heinz
authors.initials: H
authors.lastname: Gisslinger
authors.forename: Richard
authors.initials: R
authors.lastname: Greil
authors.forename: Ingrid
authors.initials: I
authors.lastname: Kuhn
authors.forename: Niklas
authors.initials: N
authors.lastname: Zojer
authors.forename: Axel
authors.initials: A
authors.lastname: Hinke
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008558:Melphalan / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D011237:Predictive Value of Tests; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D018906:Antineoplastic Agents, Alkylating; D007166:Immunosuppressive Agents; D013792:Thalidomide; D003907:Dexamethasone; D011239:Prednisolone; D008558:Melphalan